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Hyperion Therapeutics, Inc. Message Board

  • rrtzrealmd rrtzrealmd May 2, 2013 9:32 AM Flag

    Bustin' a gut laughing!... "fields59" brilliant explanation as to why HPTX has dropped over 25% in the past month:

    "down days like this are often very rough on small cap biotechs."

    ...ohhh, wait for it!..............just hold on!...........can't keep it in any longer:


    ....oh, man, that was a relief!..HAW!!...

    ....of course, the FACT that the company itself admits it will have only five HUNDRED patients who will be buying its product and the FACT that MOST of them depend on Medicaid to pay for their therapy and the FACT that, in consequence, HPTX will be FORCED to sell its product at a substantial DISCOUNT -- I guess that none of that had anything to do with thr drop, huh?...

    ...and ditto for the FACT that it was Brenda Sandburg of Elsevier Business Intelligence who pointed out that based on current numbers, revenues for HPTX will likely not exceed 30 million dollars?...

    ...and ditto for the FACT that Rhonda Greenapple, founder and CEO of Reimbursement Intelligence, said, "If they can show patients on their drug are more adherent and have better health outcomes, it’s worth the money. In order to be really successful they would need data behind it." -- the problem being that so far HPTX has absolutely ZERO data to support any claim of superiority which is why the FDA FORCES HPTX to include a disclaimer on the drug insert saying that ravicti is ONLY "non-inferior" to competing products?...

    ...and ditto for the FACT that dose adjustment of ravicti is based results of a test for levels of urinary phenylacetylglutamine which the FDA will likely FORCE HPTX to file a 510k application which will take time and money to complete?...

    ...NONE of those matter?...why, of course not! least not to SUCKERS!...HAW, HAW, HAW!!!!...

    Sentiment: Strong Sell

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    • rrtzrealmd, I'm hugely disappointed. I thought you were actually doing some original thinking about this company and it turns out you're just paying for reports and then regurgitating their analyses here. A tip: if one of the analysts has told you HPTX might be forced, *post-approval*, to file a 510k application... well that person doesn't know what a 510k application is.

      • 1 Reply to fields59
      • ...HAW!!! DIMWIT!!...that's straight out of HPTX's PROSPECTUS!!...plueeeze tell me you read their PROSPECTUS!...HAW!!!, allow me to quote it just in case you don't know how to look it up:

        "Our proposed labeling for Ravicti includes dose adjustment based on levels of urinary phenylacetylglutamine, or PAGN....A test for urinary PAGN may be considered a companion diagnostic test by the FDA. We have not discussed our PAGN-based dosing adjustment labeling strategy with the FDA and do not know whether the FDA will accept a Laboratory Developed Test or instead will consider the test a companion diagnostic and therefore require a Premarket Approval Application, a filing through the de novo reclassification process, or 510(k) clearance for a urinary PAGN test, prior to approving Ravicti. If FDA approval or clearance of a urinary PAGN test is required, any approval and launch of Ravicti could be delayed and additional costs would be required for us to reach agreement with a clinical laboratory or a third-party in vitro diagnostic test manufacturer to seek and obtain premarket approval, de novo reclassification, or premarket clearance from the FDA. The State of New York approval process, and the FDA premarket review process if required, can be lengthy and would require submission of clinical study data."

        ...HAW!!...I guess if ignorance is bliss, you must be living in seventh heaven!...TYPICAL biotech investor!!...HAW, HAW, HAW!!!!...

        Sentiment: Strong Sell

46.080.00(0.00%)Apr 23 4:00 PMEDT